Percutaneous Transluminal Coronary Angioplasty – PTCA catheters are minimally invasive cardiovascular devices used to dilate stenotic (narrowed) coronary arteries or bypass grafts and restore adequate myocardial blood flow. Widely used in interventional cardiology procedures, these catheters are inserted percutaneously and guided through the vasculature to the target lesion. A PTCA catheter consists of a specialized balloon that is hydraulically inflated to widen the blocked vessel and improve perfusion. Typical features include a flexible catheter shaft, an inflatable balloon with defined compliance, diameter, and length, and radiopaque markers for fluoroscopic visualization. They are designed with single or dual lumens to allow guidewire passage and controlled balloon inflation and deflation.

Intended Use of PTCA (Percutaneous Transluminal Coronary Angioplasty) Catheters

Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters are intended to dilate stenotic coronary arteries and coronary artery bypass grafts to improve myocardial blood flow. They are used during percutaneous coronary intervention (PCI) procedures to restore vessel patency in patients with coronary artery disease. PTCA catheters may also be indicated for pre-dilatation before stent placement and post-dilatation to optimize stent expansion, as specified in device labelling.

Intended Use: A PTCA Catheter is intended to dilate narrowed coronary arteries by inflating a balloon at the lesion site to restore vessel patency.

Device Description: A PTCA Catheter is a flexible, single-use, sterile balloon catheter system designed for coronary angioplasty procedures. It consists of a catheter shaft (single or dual lumen), an inflatable balloon located near the distal tip, radiopaque markers for fluoroscopic visualization, and a proximal hub for controlled inflation and deflation. The device is compatible with standard guidewires. The balloon is hydraulically inflated using a contrast/saline mixture to a specified Rated Burst Pressure (RBP) to dilate the stenosis. PTCA catheters are available in compliant, semi-compliant, and non-compliant (NC) configurations, with varying balloon diameters and lengths to meet specific lesion requirements.

Performance Testing for PTCA Catheters

• Balloon rated burst pressure (RBP)
• Balloon compliance testing.
• Inflation/deflation time
• Balloon fatigue testing.
• Dimensional verification (diameter & length)
• Shaft tensile strength.
• Bond strength testing
• Kink resistance.
• Push ability and trackability.
• Torque response.
• Radiopacity evaluation
• Simulated Use Testing: Trackability in tortuous path models, Crossing profile evaluation, Lesion crossing capability
• Sterilization Validation: Ethylene Oxide (EtO) or radiation validation, Residual analysis, Packaging integrity
• Shelf-life testing (accelerated and real-time)
• Biocompatibility Evaluation: PTCA catheters are blood-contacting, externally communicating devices with limited (<24 hour) contact duration. Testing typically follows ISO 10993 for: Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Systemic toxicity.

Clinical Testing:

No Guidance available for 510k submission